NCT03609346

Asian Registry of the BioFreedom Stent for STEMI Patients

Asian Registry of the BioFreedom™ BA9™ Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 914 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of these STEMI patients.

Detailed description

The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of STEMI patients. The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of STEMI patients. This will be a fully observational post market registry designed to enroll 1000 STEMI patients at about 20 centers in up to 8 Asian countries where the BioFreedom BA9 (SS) DCS is available for clinical use. The primary endpoint is LTF, which is a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization. The investigators expect event rates of the composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization to be 4.3% at one year as observed in the COMFORTABLE AMI study. Assuming a one-sided type I error (α) of 0.025, and a non-inferiority margin of 1.9%, a cohort of 1000 patients will have more than 80% power to conclude non-inferiority. The complete data analysis will be described in a Statistical Analysis Plan (SAP) that will be finalized and signed before the one year database lock. Primary and secondary endpoint related events will be adjudicated by independent adjudicators. The study will be monitored per a monitoring plan, data will be collected in an electronic data capture system. All enrolled patients will be followed up at 1, 4 and 12 months to collect information on their current status, review of cardiac medication taken and any adverse events that they have experienced. Both CERC and Biosensors will follow company SOP's which are GCP and ISO 14155:2011 compliant.

Conditions

• STEMI - ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	PCI	The placement of 1 or more stents in the diseased coronary artery lesion(s).

Timeline

• Start date: 2018-11-22
• Primary completion: 2022-01-30
• Completion: 2022-08-05
• First posted: 2018-08-01
• Last updated: 2024-02-29

Locations

5 sites across 5 countries: Hong Kong, Singapore, South Korea, Taiwan, Thailand